CClinicalTrials.gg
CompletedNCT00021983Updated Apr 29, 2015

Immunotoxin Therapy in Treating Patients With Hairy Cell Leukemia

A Phase 1 interventional study of BL22 immunotoxin in Leukemia, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-29.

Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: An immunotoxin can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia.

PURPOSE: Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients who have refractory or recurrent hairy cell leukemia.

Read the detailed description

OBJECTIVES:

  • Assess the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with refractory or recurrent CD22+ hairy cell leukemia.
  • Define the pharmacokinetics of this drug, including the terminal elimination serum half-life area under the curve and volume of distribution, in these patients.
  • Evaluate the immunogenicity of this drug in these patients.
  • Determine the effect of this drug on various components of the circulating cellular immune system in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats at least every 42 days for up to 4 courses in the absence of disease progression and sufficient neutralizing antibodies.

Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

PROJECTED ACCRUAL: A maximum of 46 patients will be accrued for this study within 3 years.

02

Conditions studied

  • Leukemia

Browse trials for

Keywords

  • refractory hairy cell leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

Browse Leukemia studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed refractory or recurrent hairy cell leukemia

    • Relapsed after less than 2 years of complete remission after purine analog therapy
    • Must have at least one of the following indications for therapy:

      • Progressive or massive splenomegaly
      • Cytopenia defined by the following:

        • Absolute neutrophil count less than 1,000/mm\^3 OR
        • Platelet count less than 100,000/mm\^3 OR
        • Hemoglobin less than 12 g/dL
      • More than 20,000 hairy cells/mm\^3
      • Symptomatic adenopathy
      • Constitutional symptoms including tumor-related fever or bone pain
  • Evidence of CD22 positivity by 1 of the following:

    • More than 15% of malignant cells from a site must react with anti-CD22 by immunohistochemistry
    • More than 30% of malignant cells from a site CD22+ by fluorescent-activated cell sorter
    • More than 400 CD22 sites/cell (average) on malignant cells as assessed by radiolabeled anti-CD22 binding
  • No CNS disease requiring treatment
  • No patients whose serum neutralizes BL22 immunotoxin in tissue culture, due to either antitoxin or antimouse-IgG antibodies

    • No patients whose serum neutralizes more than 75% of the activity of 1 microgram/mL of BL22 immunotoxin

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 6 months

Hematopoietic:

  • See Disease Characteristics
  • Pancytopenia due to disease allowed

Hepatic:

  • ALT and AST less than 2.5 times upper limit of normal (ULN)
  • Bilirubin less than 1.5 times ULN

Renal:

  • Creatinine no greater than 2.0 mg/dL

Pulmonary:

  • FEV1 at least 60% of predicted
  • DLCO at least 55% of predicted

Other:

  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior bone marrow transplantation allowed
  • At least 3 weeks since prior interferon for the malignancy
  • More than 3 months since prior monoclonal antibody therapy (e.g., rituximab)

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior cytotoxic chemotherapy for the malignancy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 weeks since prior whole body electron beam radiotherapy for the malignancy
  • Radiotherapy within the past 3 weeks allowed provided less than 10% of total bone marrow was treated and patient has measurable disease outside the radiation port

Surgery:

  • Not specified

Other:

  • At least 3 weeks since prior retinoids for the malignancy
  • At least 3 weeks since any other prior systemic therapy for the malignancy
  • No concurrent therapeutic warfarin
05

Study design

Phase
Phase 1
Primary purpose
Treatment

Interventions

  • BiologicalBL22 immunotoxin
06

Study locations

1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    Bethesda, Maryland 20892-1182, United States
07

References and documents

Publications

  • Matsushita K, Margulies I, Onda M, Nagata S, Stetler-Stevenson M, Kreitman RJ. Soluble CD22 as a tumor marker for hairy cell leukemia. Blood. 2008 Sep 15;112(6):2272-7. doi: 10.1182/blood-2008-01-131987. Epub 2008 Jul 2. PubMed 18596230 ↗
  • Kreitman RJ, Squires DR, Stetler-Stevenson M, Noel P, FitzGerald DJ, Wilson WH, Pastan I. Phase I trial of recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) in patients with B-cell malignancies. J Clin Oncol. 2005 Sep 20;23(27):6719-29. doi: 10.1200/JCO.2005.11.437. Epub 2005 Aug 1. PubMed 16061911 ↗
  • Kreitman RJ, Wilson WH, Bergeron K, Raggio M, Stetler-Stevenson M, FitzGerald DJ, Pastan I. Efficacy of the anti-CD22 recombinant immunotoxin BL22 in chemotherapy-resistant hairy-cell leukemia. N Engl J Med. 2001 Jul 26;345(4):241-7. doi: 10.1056/NEJM200107263450402. PubMed 11474661 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00021983
Lead sponsor
National Cancer Institute (NCI)
First posted
Dec 12, 2003
Start date
Dec 1998
Last update
Apr 29, 2015

Study contacts

Robert Kreitman, MD
study chair · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion